68 Qa Engineer jobs in Ireland

Exclusivity: This position is being managed exclusively by Pale Blue Dot® Recruitment on behalf of our client. All applications and enquiries will be managed directly through ourselves.

Are you a driven and experienced Quality Engineer looking for your next big opportunity?

A leading medical device company based in Bray,  Wicklow is currently seeking a skilled and motivated  Senior Quality Assurance Engineer  to join their team. Are you a quality professional who’s ready to take on increased responsibility, mentor others, and drive excellence in a high-performing, regulated environment. This opportunity offers real career progression, exposure to a wide range of quality systems and activities, and the chance to make a meaningful impact in a company that values continuous improvement, innovation, and teamwork.

Responsibilities include but are not limited to:

• Lead and manage root cause investigations, ensuring timely and effective NCR and  CAPA implementation.

• Assist the QA Manager with the  day-to-day QMS management, ensuring compliance with ISO 13485 and all relevant regulatory requirements.

• Conduct and support internal audits, driving ongoing compliance and quality improvements.

• Support and oversee validation activities, including process validations, test method validations, and risk assessments.

• Provide hands-on quality support for manufacturing, ensuring product compliance and process control.

• Develop, implement, and maintain SOPs and work instructions to drive quality initiatives and support operations.

• Act as a key contact for customer quality concerns, complaints, and regulatory inquiries, leading investigations where required.

• Identify and lead continuous improvement projects to enhance efficiency and product quality.

• Mentor and support junior quality team members, contributing to a culture of learning and professional growth.

• Assist in supplier quality management, ensuring robust quality agreements and ongoing compliance.

• Own and manage the PM/Calibration schedule.

• Assist with the development of other quality personnel as required.

• A Bachelor’s degree in Engineering, Quality, Life Sciences, or a related discipline

• 5+ years’ experience in a medical device or regulated manufacturing environment

• Proven experience with root cause analysis, CAPA management, and failure investigations

• Training in ISO 13485 internal auditing (lead auditor certification preferred but not essential)

• Strong understanding of quality engineering tools and principles such as FMEA, SPC, risk management, and validation

• Excellent analytical and problem-solving skills, with a data-driven mindset

• Effective communication and interpersonal abilities, with a collaborative approach

• Proficiency in Microsoft Office Suite and quality management software

  Why Apply ?

• An opportunity to step up to senior-level responsibilities

• A forward-thinking, collaborative environment that encourages creativity, autonomy, and professional growth

• Direct influence on product quality, process improvements, and team development

• Join a company making a real difference in patients’ lives through high-quality medical device technology.

This is a fantastic opportunity to join a forward-thinking team and thrive in a collaborative, supportive environment that values creativity and teamwork!

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

-Pale Blue Dot® Recruitment - The Resource for the MedTech Workforce-

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are currently recruiting a QC Analyst for our high-performing team in Manorhamilton Rd, Sligo. This is a 12 month fixed-term contract. This is also a rotating shift position.
A snapshot of your key responsibilities as a QC Analyst would be:
+ Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements.
+ Understand Regulations and business processes required to maintain Laboratory Data Integrity.
+ Be responsible for housekeeping duties in the lab.
+ Be responsible for the timely completion of chemical testing of raw material.
+ Ensure that all test equipment is used and maintained correctly.
+ Be responsible for raising change requests and data verification as assigned.
+ Ensure all in-process sampling and testing are completed in a timely manner.
+ Maintain up-to-date, complete, and precise records of all tests performed.
+ Adhere to cGMP and GLP requirements.
+ Assist in the resolution of quality problems as required.
+ Develop and change in-house laboratory procedures as appropriate.
+ Aid in training of new analyst.
+ Support the transfer of new products.
+ Adhere to and support all EHS & E standards, procedures and policies.
Qualifications
+ 3rd level qualification in a relevant Science discipline required.
+ A minimum of 6 months of experience in HPLC or GC.
+ Experience operating to cGMP standards utilizing laboratory equipment.
+ Previous experience in a pharmaceutical manufacturing environment is desirable but not essential.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are looking for a QC Manager to join our team on our Manorhamilton Road site in Sligo. The QC Lab Manager is integral to managing a team responsible for QC testing, ensuring adherence to product specifications, quality, and safety goals. This role involves overseeing laboratory operations, including analytical testing for API and OSD products, and coordinating with internal teams to meet testing schedules.
Responsibilities:
+ Manage a lab team performing QC testing, ensuring compliance with data integrity policies and regulatory requirements.
+ Conduct and supervise all aspects of API and OSD analytical testing.
+ Ensure timely sampling, inspection, and testing, coordinating with teams for schedules and priorities.
+ Participate in internal and external audits and address audit findings.
+ Prepare technical reports, lead investigations, and implement CAPAs.
+ Provide training and support to lab team to achieve daily and long-term goals.
+ Present technical data to stakeholders to facilitate prompt decision-making.
+ Report to the Senior QC Manager.
Qualifications
+ M.Sc./B.Sc. in Chemistry or a related discipline.
+ Minimum 4 years of experience in people management within a pharmaceutical lab setting.
+ Strong knowledge of QA/QC operations, analytical testing for API and OSD.
+ Excellent presentation and technical report writing skills.
+ Strong communication and interpersonal skills, with a commitment to quality and compliance.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Within this role you will be responsible for the oversight of Quality Control support operations. As a Manager within Quality Control a typical day might include, but is not limited to, the following: Maintaining oversight of QC equipment lifecycle activities (including procurement, installation, qualification, maintenance, and decommissioning) Providing direction to Managers and staff that support the equipment Ensuring equipment qualification and maintenance programs are aligned with regulatory agencies requirements, qualified and available for QC laboratory usage Interacting with QC partner groups to establish internal requirements for equipment Leading QC equipment validation / qualification efforts through partnering and interaction with QA Validation and IT groups Managing oversight of the preventive and corrective maintenance monitoring program Managing oversight of the QC external laboratories activities and performance monitoring of external testing laboratories Supervising the issuance and approval of Quality agreements and SLAs with the contract labs Verifying that the site Manufacturing licence and global procedures reflect current contract lab utilization Identifying and calling out issues at contract laboratories to QC leadership Sourcing, co-ordinating and project management of GMP activities relating to new contract lab introduction Travel may be required in support of external contract laboratory testing activities Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations Responsibility for equipment automation and associated projects This role might be for you if you: Possess strong communication and interpersonal skills Demonstrate logical troubleshooting and problem-solving skills Have a detailed understanding of equipment qualification and maintenance activities and industry compliance norms Have the ability to communicate effectively with multiple partners Enjoy working in a fast-paced environment Demonstrate a collaborative and team-orientated approach To be considered for this opportunity you should have a BA/BS in chemistry, biology or related field with 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
We're excited to invite you to lead our Quality Control (QC) Chemistry Laboratory team in our purification and aseptic filling facility at Grifols Worldwide Operations (GWWO). As **QC Chemistry Manager** , you will play a key role in ensuring high-quality laboratory testing of clean utility, raw material, in-process and final container materials, maintaining full compliance with current Good Manufacturing Practices (cGMP) and safety standards.
**Key Responsibilities:**
- Management of the QC Chemistry team to carry out required chemistry, immunochemistry and protein testing as required
- Ensure QC testing of clean utility, raw material, in-process and final container testing is performed as per the production plan
- Manage integrity of Laboratory Data
- Ensure all methods are qualified/validated in line with site procedures and regulatory/compendial requirements
- Ensure all equipment is validated, maintained, calibrated, and requalified in line with site procedures and regulatory/compendial requirements
- Creation, review and update of test methods and SOPs to ensure all aspects of compliance are adhered to
- Drive and oversee process/product/OOS/deviation investigations
- Implementation of Corrective and Preventative Actions
- Maintain, monitor and report QC Chemistry metrics and KPIs
- Ensure training and development of QC Chemistry team members in conjunction with team development and goals via the performance management process
- Represent QC Chemistry in any regulatory, corporate or internal audits
- Ensure regular Quality interaction with other departments within GWWO and Grifols sister sites
- Support site quality activities, including but not limited to: Annual Product Quality Reviews (APQRs), recall activities, change control etc.
- Responsible for any projects impacting QC Chemistry such as Method Transfers, Process Improvement or Harmonisation Projects
- Keep Abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
- Manage the safety and performance of QC Chemistry in line with safety regulations and site procedures
- Perform additional duties as assigned
- Act as a delegate for activities performed by the QC Senior Manager for QC Chemistry activities
**Knowledge & Skills:**
- Full understanding of relevant cGMP, quality and compliance regulations
- Experience with chromatography instrumentation and methods
- Experience with protein chemistry instrumentation and methods
- Method Transfer and qualification experience
- Understanding of pharmacopoeial requirements and methods
- Excellent communication skills at organisation, team and individual levels
- Demonstrated problem solving skills
- Strong decision making skills
- Strong presentation skills
- Ability to manage multiple projects to plan/budget
- Experience in developing analytical methods is desirable
- Experience with Statistical Process Control (SPC) is desirable
- Experience with Lab Management Systems & SAP is desirable
**Qualifications:**
- BSc or equivalent in chemistry, biochemistry, pharmaceutical science or related field
- Minimum 3 years supervisory/management experience
- 8 years progressive experience as an individual contributor in a fast paced GMP Laboratory environment
- M.Sc. qualification is desirable but not essential
**Our Benefits Include:**
+ Highly competitive salary
+ Group pension scheme - Contribution rates up to 7%
+ Private Medical Insurance for the employee
+ Ongoing opportunities for career development in a rapidly expanding work environment
+ Succession planning and internal promotions
+ Education allowance
+ Wellness activities - Social activities eg. Golf, Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply - we're excited to hear from you.
#LI-FD1
**Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 ( more about Grifols
**Req ID:**
**Type:** Regular Full-Time
**Job Category:**

Junior to Mid-Level Quality Control/Validation Engineer IRELAND, IRELAND / NORTH EUROPE / FULL TIME About CAI: CAI is a 100% employee-owned company established in 1996, growing year over year to nearly 700 employees worldwide. We provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness in FDA regulated and other mission-critical industries. Are You Ready?: Our approach is simple: we put the clients interests first, we do not stop until it is right, and we will do whatever it takes to get there. As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally: - We act with integrity - We serve each other - We serve society - We work for our future With employee ownership, one persons success is everyones success. We work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially. CAI agents will be exposed to cutting-edge technologies in the advanced medicine space, working alongside recognized subject matter experts. As part of our culture, we invest in YOUR future through hands-on certifications and professional training. Position Overview: We are looking for a Junior to Mid-Level Validation Engineer to join our growing operations in Ireland. This role is designed for individuals with at least 2 years of relevant experience in Validation Engineering or Quality Control. As a Junior to Mid-Level Engineer, you will work alongside senior team members, assisting in maintaining quality standards and ensuring compliance throughout all equipment qualification activities. Key Responsibilities: - Support and assist with Quality Control compliance for equipment qualification activities, ensuring adherence to safety and regulatory standards. - Help document and execute equipment qualification processes, from initial assessments to Operational Qualification (OQ), focusing on accuracy and attention to detail. - Follow established procedures and protocols for new equipment qualification to help embed quality practices within workflows. - Assist with the review and completion of Test Outlines and Procedures (TOPs), verifying alignment with quality specifications. - Support the planning and organization of commissioning materials and consumables, ensuring they meet required quality standards. - Monitor equipment qualification activities to ensure that timelines are met while maintaining high quality standards. - Assist in preparing and maintaining Qualification Summary Reports (QSRs) and related documentation to ensure compliance with quality standards. - Participate in equipment Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), with a focus on achieving quality outcomes. - Assist in managing quality control processes related to equipment qualifications, including documentation control, change controls, and punch list tracking. - Collaborate with project contractors and equipment vendors to perform and verify tests, ensuring quality control is upheld. - Provide support for quality assurance tasks throughout the equipment qualification process, ensuring consistent quality standards are maintained. Position Requirements: - BS or MS in a relevant science or engineering field, or equivalent experience. - 2+ years of industry-related experience in a similar role. - Strong oral and written communication skills, with a focus on clear documentation and reporting. - Strong problem-solving skills with a focus on Quality Control. - Customer-service oriented and able to collaborate well with internal teams and external vendors. - Familiarity with life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or equivalent experience. - Willing and able to travel domestically and internationally, if required. Skills: Quality Control QC Technican Equipment Validation Life Science Bio-Pharma Pharmaceutical Manufacturing Benefits: Pension Fund Medical Aid / Health Care Dental Care Income Protection Group Life Assurance

**Our Story**
Unum Technology Centre in Carlow serves as a strategic software development and IT services centre supporting Unum, a leading provider of income protection in the US. Our team of IT professionals build solutions and critical business applications to digitally transform the way we do business.
We are seeking a highly skilled Manual and Automated Software Test Engineer to join our team. As a pivotal member of our development team, you will play a crucial role in ensuring the quality and reliability of our applications through both manual and automated testing methodologies.
**The Role**
- Develop and execute manual test plans as well as automated test scripts to verify the functionality, performance and reliability of applications.
- Collaborate with cross-functional teams to understand requirements and design comprehensive test plans.
- Create and maintain test data sets to support various testing scenarios, including positive and negative test cases.
- Implement and maintain automated test frameworks, leveraging tools such as Selenium, Cucumber, or similar technologies.
- Identify, analyze and report software defects, working closely with developers to ensure timely resolution.
- Continuously monitor and improve test coverage and test efficiency through automation.
- Participate in Agile ceremonies, including sprint planning, daily stand-ups, and retrospectives.
- Collaborate with developers and business analysts to enhance testability and quality throughout the software development lifecycle.
- Stay updated on industry best practices and emerging trends in automated testing and integration testing methodologies.
- Mentor junior team members and contribute to the overall improvement of the testing process.
**What you offer**
- Bachelor's degree in Computer Science, Engineering, or related field.
- Manual testing, strong automation with Java & Rest Assured, Postman, any CI/CD tools (i.e. Azure DevOps)
- 4+ years of experience in manual and automated software testing.
- Solid understanding of software development lifecycle (SDLC) and Agile methodologies.
**Beneficial Skills**
- Excellent problem-solving skills and attention to detail.
- Strong communication and collaboration skills, with the ability to work effectively in a team environment.
- Knowledge of Mainframe technologies would be an advantage.
#LI-SF1
**#LI-Hybrid**
#Hybrid
**What We Offer**
Our size and successful history in Carlow means we can offer you exceptional development and progression, supported by continual learning programs, IT Certifications & third level tuition reimbursement. We offer work-life-balance with flexible working arrangements (including hybrid) and initiatives in support of your well-being. Our attractive range of benefits and reward initiatives includes competitive compensation, 25 days annual leave, paid health insurance, pension scheme, annual performance-based bonus, paid maternity/paternity/adoptive leave, reward programs, and an opportunity to engage with charity and community activities.
Company:
Unum

GerTEK Project Management & Technical Services are hiring for an experienced QA Validation Professional to join our team. The QA Validation Engineer is responsible for the Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with clients policies, FDA, European cGMP and GAMP standards. Responsibilities To coordinate the development and maintenance of the site validation program and ensure clien and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities. Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European cGMP and GAMP standards. Generation/maintenance/execution of the Site Validation Master Plan. Generation/maintenance/execution of Project Validation Plans and schedules. Generation of validation protocols and final reports to cGMP standards. Generation of validation investigations and implementation of corrective actions. Creation/Review/Approval of various quality documents and test data. Management of validation, exception event, and change control processes. Maintenance and tracking of validation equipment, if applicable. Completing all required training before executing a task. Documenting all activities in line with cGMP requirements. Updating of validation procedures, job instructions and batch documentation to reflect current best practices. Performing cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems. Coordinating activities to maximize the effectiveness of all of the team members. Maintaining the overall cGMP compliance of the production areas. Communicating with peers and management regarding activities in the area, including elevation of events or concerns. Requirements Qualification and/or degree in engineering or scientific discipline. Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations or similar industry. 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry. To start the process click the Continue to Application or Login/Register to apply button below.

Our client is seeking a QA Validation Engineer to join their team at their Sligo Facility. Responsibilities To coordinate the development and maintenance of the site validation program and ensure AbbVie and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities. Coordination / direction and active participation in the validation and quality assurance. Generation/maintenance/execution of the Site Validation Master Plan. Generation/maintenance/execution of Project Validation Plans and schedules. Generation of validation protocols and final reports to cGMP standards. Generation of validation investigations and implementation of corrective actions. Creation/Review/Approval of various quality documents and test data. Management of validation, exception event, and change control processes. Maintenance and tracking of validation equipment, if applicable. Completing all required training before executing a task. Documenting all activities in line with cGMP requirements. Updating of validation procedures, job instructions and batch documentation to reflect current best practices. Performing cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements Coordinating activities to maximize the effectiveness of all of the team members. Maintaining the overall cGMP compliance of the production areas. Communicating with peers and management regarding activities in the area Essential Requirements Qualification and/or degree in engineering or scientific discipline. Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations. 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry. Strong communication (written and oral), presentation and troubleshooting skills required Effective interpersonal and organizational skills. Ability to work well both independently and in a team environment. Capable of prioritizing work and multitasking. For a confidential discussion and more information on the role, please contact Emma Daly Skills: moulding and assembly knowledge of automated lines validation